Drug product
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
D-0275-2024
Product summary
- Event
- Event 93740
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,672 30-count bottles
- Official record key
drug-enforcement:D-0275-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # 100047273; Exp. 07/2025
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications